A phase 3 study evaluating the safety and efficacy of relugolix (Myovant Sciences), an investigational oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in combination with estradiol 1.0mg and norethindrone 0.5mg in women with uterine fibroids, met its primary endpoint.
In LIBERTY 1, patients with uterine fibroids and heavy menstrual bleeding (N=388) were randomized to receive either relugolix combination therapy once daily for 24 weeks, relugolix 40mg once daily monotherapy for 12 weeks followed by relugolix combination therapy once daily for an additional 12 weeks, or placebo once daily for 24 weeks. The primary endpoint of the study was the proportion of women who achieved menstrual blood loss volume of <80mL and a ≥50% reduction from baseline in menstrual blood loss volume during the last 35 days of the 24-week treatment period (responder criteria).
Results showed that 73.4% of patients in the relugolix combination group achieved the responder criteria compared with 18.9% of those in the placebo group (P <.0001). In addition, relugolix combination therapy was associated with a significant reduction in menstrual blood loss from baseline (P <.0001), a reduction in pain (P <.0001), and an improvement in quality of life (P <.0001), all key secondary endpoints. Moreover, the combination therapy maintained bone mineral density at levels comparable to placebo.”
“We are incredibly pleased with the positive results of this first phase 3 study demonstrating a clinically meaningful response in a high proportion of women while maintaining bone health,” said Lynn Seely, MD, President and Chief Executive Officer of Myovant. “These results substantiate our once daily oral combination therapy approach.
Results from a replicate study (LIBERTY 2) are expected in the third quarter 2019 and if successful, the Company plans to submit a New Drug Application (NDA) in the fourth quarter 2019.
For more information visit Myovant.com.